Catheter insertion device

ABSTRACT

A catheter insertion device that allows for single-handed insertion of the catheter within the vasculature of the patient is disclosed. The catheter insertion device includes a handle, a needle cannula partially within the handle, a guidewire partially within the handle and the needle cannula, and a first actuator connected to the handle and the guidewire. The guidewire is movable relative to the handle in a distal direction away from the handle, and in a proximal direction towards the handle. A catheter assembly is removably coupled to the handle and is configured to slide on the needle cannula. A catheter hub may be connected to a proximal end of the catheter, and a catheter advancer base may be releasably connected to the catheter hub. The catheter insertion device may also include a needle support pivotally connected to the handle for supporting the needle cannula on a cantilever portion thereof.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/950,507, filed on Apr. 11, 2018, which claims the benefit of U.S.Provisional Patent Application No. 62/485,167, filed on Apr. 13, 2017,the disclosures of which are hereby incorporated by reference in theirentirety.

TECHNICAL FIELD

This disclosure generally relates to medical devices for use in theinsertion of catheters or other medical equipment into the vasculatureof a patient. More particularly, this disclosure relates to a catheterinsertion device for at least partial insertion of a catheter within thevasculature of the patient.

BACKGROUND

Different types of medical devices, such as needles, introducers,trocars, catheters, stents, angiography balloons, cutting tools, andimaging tools can be introduced into the body for various medicalprocedures. For example, catheters are used to introduce or removefluids from vessels in the body for a variety of medical procedures. Ina typical procedure, to insert a catheter in a vessel, the vessel accessis first verified by aspiration using a long hollow needle, such as asyringe needle. A guidewire is then passed through the needle into thevessel. The guidewire acts as a track for the catheter to pass over toreach a target location within the vessel. A catheter is finally passedover the guidewire to the target location in the vasculature of thepatient. With the catheter in place, the needle and the guidewire areremoved, leaving only the catheter in the vessel. Fluids are thenintroduced or removed from the vessel through the catheter by connectinga fluid source or aspiration device to the catheter hub.

Various devices are known for placement of a catheter in the vasculatureof a patient. Maintaining sterility of the various components of thedevice by, for example, preventing the contact of the fingers of theoperator with the various parts of the needle, the guidewire, and thecatheter itself during operation, is important for use of these devices.However, conventional catheter placement devices typically require theuse of two hands for the insertion of the guide wire and advancement ofthe catheter into the vasculature, which increases the risk ofcontamination and also increases the risk of inadvertently damaging thevessel due to unintended needle point movement. Moreover, conventionalcatheter placement devices also prevent the continuous use of ultrasoundfrom the point of skin penetration, vessel access, and wire guideinsertion, through to having the first distal portion of the catheter inthe vessel and needle point shielded. This makes such conventionalcatheter placement devices less convenient for use. Additionally, theaforementioned drawbacks of conventional catheter placement devicesaffect the success rate of insertion into the vasculature.

Therefore, a need exists for a novel catheter insertion device thatallows for single-handed insertion of the catheter within thevasculature of the patient. Additionally, a need exists for a catheterinsertion device that allows for easy, safe, and fast catheter placementinto a patient's vasculature.

SUMMARY

The foregoing needs are met, to a great extent, by implementations of acatheter insertion device according to the present disclosure. Inaccordance with one implementation, a catheter insertion device mayinclude a handle having a proximal body portion and two cantilever armseach extending distally from said body portion; a needle cannula havinga proximal end located within the handle proximal body portion, saidneedle cannula extending distally from the handle proximal body portionand defining a distal cantilever portion disposed partially between thetwo cantilever arms of the handle; a catheter assembly removably coupledto the handle and configured to slide on the needle cannula, thecatheter assembly comprising an elongated catheter, a catheter hubconnected to a proximal end of the elongated catheter, and a catheteradvancer base connected to the catheter hub; and a needle support havingtwo parallel walls pivotally connected to the handle, said needlesupport pivoting between a first position and second position, saidneedle support configured to support the needle cannula on thecantilever portion of said needle cannula when the needle support is inthe first position and said needle cannula is disposed between said twoparallel walls of the needle support, said needle support blockingdistal advancement of the catheter assembly when said needle support isin the first position.

In some implementations, the catheter insertion device may comprise aguidewire and a guidewire actuator for extending or retracting theguidewire, wherein the needle support cannot pivot away from the firstposition before the guidewire actuator is moved to extend the guidewiredistally past a tip of the needle cannula.

In some implementations, the two arms of the handle comprise a top armand a bottom arm, and the catheter advancer base slidably engages thebottom arm of the handle.

In some implementations, the catheter advancer base may include a guidetrack configured to receive the bottom arm of the handle for moving thecatheter assembly in a distal direction relative to the handle and in aproximal direction relative to the handle, and wherein the guide trackprevents twisting of the catheter assembly during movement of thecatheter assembly in both the distal and proximal directions.

In some implementations, the catheter advancer base may include a pairof grip arms for supporting a choked up hand position by a user.

In some implementations, the needle support is pivotally connected to adistal portion of the top arm of the handle and configured to moverelative to the handle upon abutment of the catheter advancer base tothe needle support.

In some implementations, the needle support is configured to pivotrelative to the handle about a pivot axis perpendicular to an axis ofthe needle cannula.

In some implementations, the needle support may further comprise a hookportion configured to releasably mate with the bottom arm of the handlewhen said needle portion is in the first position.

In some implementations, moving the guidewire actuator in a proximaldirection relative to the handle causes a distal end of the guidewire tomove in a distal direction away from the handle, and moving theguidewire actuator in a distal direction relative to the handle causesthe distal end of the guidewire to move in a proximal direction towardsthe handle.

In some implementations, the catheter insertion device may comprise acatheter assembly actuator connected to the handle, the catheterassembly actuator being movable relative to the handle to push thecatheter assembly distally relative to the handle.

In some implementations, the catheter advancer base may further comprisea seat portion configured to stably secure the catheter and catheterhub.

In some implementations, the catheter advancer base may further comprisea retaining member configured to secure the catheter hub.

In some implementations, the needle support may further comprise atextured surface to aid gripping.

In some implementations, the needle cannula may further comprise a sharpdistal tip extending distally from the handle, the distal tip having aback-grind portion defining a gradual taper.

In some implementations, the guidewire further has a variable stiffness.

In some implementations, the needle cannula further comprises a swagehaving an oval-shaped cross section bulge near a distal tip of theneedle cannula.

In some implementations, a catheter insertion device comprises: a handlehaving a body portion and an arm extending distally from the bodyportion; a needle cannula partially within the handle, the needlecannula comprising a sharp distal tip extending distally from thehandle; a catheter assembly removably coupled to the handle, thecatheter assembly comprising an elongated catheter, a catheter advancerbase having a seat portion, and a catheter hub connected to theelongated catheter and matingly received in the seat portion of thecatheter advancer base; and a needle support connected to the handle andmovable between a first position and a second position, the needlesupport configured to stabilize lateral movement of the needle cannulawhen in the first position, and the needle support configured to blockdistal advancement of the catheter assembly when in the first position.

In some implementations, the needle support is configured to permitdistal advancement of the catheter assembly when in the second position.

In some implementations, the catheter insertion devices furthercomprises a guidewire partially disposed within the handle, and a firstactuator connected to the handle and the guidewire, the first actuatormovable between an extended position where the first actuator abuts theneedle support when the needle support is in the first position, and aretracted position where the first actuator does not abut the needlesupport when the needle support is in the first position, and whereinmoving the first actuator between the extended and retracted positionscauses the guidewire to move relative to the handle.

In some implementations, the catheter insertion device further comprisesa second actuator connected to the handle and configured to move thecatheter assembly distally relative to the handle and move the needlesupport from the first position to the second position when the firstactuator does not abut the needle support.

Certain implementations of the catheter insertion device have beenoutlined so that the detailed description below may be betterunderstood. There are, of course, additional implementations that willbe described below and which will form the subject matter of the claims.In this respect, it is to be understood that the catheter insertiondevice is not limited in its application to the details of constructionand to the arrangements of the components set forth in the followingdisclosure or illustrated in the drawings. Also, it is to be understoodthat the phraseology and terminology employed herein are for the purposeof description and should not be regarded as limiting. As such, theconception upon which this disclosure is based may readily be utilizedas a basis for the designing of other structures, methods, and systemsfor carrying out the several purposes of the catheter insertion device.It is understood, therefore, that the claims include such equivalentconstructions insofar as they do not depart from the spirit and scope ofthe present disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates a top perspective view of an implementation of acatheter insertion device including a catheter group and an insertiongroup.

FIG. 1B illustrates a side elevation view of the catheter insertiondevice of FIG. 1A.

FIG. 2A illustrates an exploded view of the separate components of thecatheter group of the catheter insertion device.

FIG. 2B illustrates a partially transparent perspective view of theassembled catheter group of the catheter insertion device.

FIG. 3A illustrates a partially exploded view of the catheter insertiondevice.

FIG. 3B illustrates a top perspective view of the catheter insertiondevice having a protective needle guard.

FIG. 3C illustrates a side elevation view of the catheter insertiondevice having a protective needle guard.

FIG. 3D illustrates an enlarged bottom perspective view of a portion ofthe catheter insertion device.

FIG. 3E illustrates an enlarged top perspective view of a portion of thecatheter insertion device.

FIG. 3F illustrates an enlarged side elevation view of a portion of thecatheter insertion device.

FIG. 3G illustrates the catheter insertion device having a slider in aretracted position and a needle support in an upright position.

FIG. 3H illustrates an enlarged bottom perspective view of a portion ofthe catheter insertion device having a protective needle guard.

FIG. 4A illustrates a top perspective view of a catheter advancer baseand a needle support.

FIG. 4B illustrates a top perspective view of the catheter advancerbase, the needle support, and the assembled catheter group.

FIG. 5A illustrates a cross-sectional side view of a right housing of anassembled catheter insertion device.

FIG. 5B illustrates a cross-sectional view of a handle of an assembledcatheter insertion device.

FIG. 6 illustrates a side elevation view of a portion of a slider of theinsertion group of the catheter insertion device.

FIG. 7A illustrates a release of the insertion group of the catheterinsertion device and a catheter advancer base, as well as a partialcut-away view of a handle of the catheter insertion device.

FIG. 7B illustrates an enlarged view of the release of the insertiongroup of the catheter insertion device without the catheter advancerbase.

FIG. 7C illustrates a side view of the release in an extended position.

FIG. 8A illustrates a perspective view of a region of the assembledcatheter insertion device having the slider in a fully extended positionand the release in a fully retracted position.

FIG. 8B illustrates a cross-sectional side view of a region of thecatheter insertion device along the center longitudinal plane of thehandle in a pre-advanced position of the catheter group.

FIG. 8C illustrates a cross-sectional side view of the region of thecatheter insertion device along the center longitudinal plane of thehandle following actuation of the slider by the practitioner.

FIG. 8D illustrates a cross-sectional side view of the region of thecatheter insertion device along the center longitudinal plane of thehandle following actuation of the release by the practitioner.

FIG. 8E illustrates a cross-sectional side view of the region of thecatheter insertion device along the center longitudinal plane of thehandle following further advancement of the catheter group along thehandle by the practitioner.

FIG. 8F illustrates a side view of the region of the catheter insertiondevice following advancement of the catheter group from the handle bythe practitioner.

FIG. 9A illustrates a perspective view of a needle safety clip mountedto a catheter hub of the catheter group of the catheter insertiondevice.

FIG. 9B illustrates a rear view of the needle safety clip.

FIG. 9C illustrates a front view of the needle safety clip.

FIG. 9D illustrates an enlarged perspective view of the needle safetyclip released from the catheter hub of the catheter group of thecatheter insertion device.

FIG. 9E illustrates a perspective view of an implementation of a sharpneedle tip of the needle according to the present disclosure.

FIG. 9F illustrates the sharp needle tip being withdrawn from the needlesafety clip.

FIG. 10A illustrates the insertion group being pulled proximally to thepoint where the sharp needle tip of the needle is between two distalwalls of the needle safety clip.

FIG. 10B illustrates the insertion group being pulled proximally to thepoint where the sharp needle tip of the needle is proximal of both thetwo distal walls of the needle safety clip and is tilted relative to theneedle safety clip.

FIG. 11A illustrates a perspective view of an implementation of a sealhaving two parts according to the present disclosure.

FIG. 11B illustrates a proximal part of the two-part seal of FIG. 11A.

FIG. 11C illustrates a distal part of the two-part seal of FIG. 11A.

FIG. 11D illustrates a partial cross-sectional view of seal of FIG. 11Awithin the catheter hub of the catheter group.

FIG. 12 illustrates a perspective view of a distal region of the needleshowing a plurality of echogenic features.

Implementations of the catheter insertion device are described withreference to the drawings, in which like reference numerals refer tolike parts throughout.

DETAILED DESCRIPTION

Referring to FIGS. 1A and 1B, an implementation of a catheter insertiondevice 100 including a catheter group 102 and an insertion group 104 isillustrated. The insertion group 104 may be separated from the cathetergroup 102 following partial insertion of a catheter 106 in thevasculature of a patient. The catheter group 102 also includes anextension line assembly 108 in fluid communication with the catheter106. The extension line assembly 108 may be connected to a fluid sourceor an aspiration device. The insertion group 104 includes a handle 110that is initially connected to the catheter group 102 and thatfacilitates the insertion of the catheter 106 in the vasculature of thepatient.

FIG. 2A illustrates an exploded view of the separate components of thecatheter group 102 of the catheter insertion device 100. Referring toFIG. 2B, a partially transparent perspective view of the assembledcatheter group 102 of the catheter insertion device 100 is illustrated.At its proximal region, the catheter group 102 includes an extensionline assembly 108 that includes an elongated extension line 112, anextension line clamp 114, and an extension line hub 116. A vent plug, asshown in FIG. 1A, may further be attached to the extension line hub 116during insertion of the needle and then removed prior to use by thepractitioner, i.e. before the practitioner connects a syringe to theextension line hub 116. The elongated extension line 112 defines anelongated lumen that is in fluid communication with the lumen defined bythe catheter 106 through the lumen defined by a rigid hub 120. Theextension line clamp 114 is received around the elongated extension line112 and may be slid in a direction perpendicular to the longitudinalaxis of the elongated extension line 112 to pinch the elongatedextension line 112 closed. When the extension line clamp 114 pinches theelongated extension line 112, fluid is prevented from flowing beyond theextension line clamp 114 either distally towards the catheter 106 orproximally towards the extension line hub 116. The extension line hub116 defines a lumen that is in fluid communication with the lumendefined by the elongated extension line 112.

In some implementations, the lumen defined by the extension line hub 116may be tapered from its proximal end towards its distal end, while inother implementations, the lumen defined by the extension line hub 116may have a uniform diameter. The proximal end of the extension line hub116 includes a connector, such as a threaded luer lock, for connectionto a fluid source or an aspiration device. The fluid source may be asyringe or an intravenous bag, among others.

At its distal end, the catheter group 102 includes the elongatedcatheter 106 that is connected to a catheter hub 118. In particular, theproximal end of the elongated catheter 106 connects to the distal end ofthe catheter hub 118. The rigid hub 120 is partially received within theproximal end of the catheter hub 118. The rigid hub 120 receives a seal218 that acts as a valve within an internal cavity defined by the rigidhub 120. The proximal end of the rigid hub 120 is sealed by a rigid hubcap 124. The proximal end of the rigid hub cap 124 has an opening thatallows the needle cannula 130 and the guidewire 132 to pass through therigid hub cap 124 to the seal 218. The elongated catheter 106 defines anelongated lumen that is at least partially received within thevasculature of the patient. The catheter hub 118 defines a taperedcavity that is in fluid communication with the lumen defined by theelongated catheter 106 and the lumen defined by the rigid hub 120. Therigid hub 120 also includes a side port 121 for receiving the elongatedextension line 112 of the extension line assembly 108. The lumen definedby the side port 121 is in fluid communication with the lumen defined bythe elongated extension line 112.

The seal 218 is a multi-piece seal, as described in greater detailbelow. In other implementations, the seal may be one-piece seal, asdescribed in U.S. patent application Ser. No. 14/306,698, filed Jun. 17,2014, the full disclosure of which is incorporated herein by referencein its entirety. When the catheter group 102 is assembled, the seal 218is enclosed by the rigid hub 120 and the rigid hub cap 124. In someimplementations, the catheter group 102 may not include the extensionline assembly 108 and the fluid source or aspiration device can beconnected to a proximal end of the rigid hub 120.

Referring to FIG. 3A, an exploded view of the separate components of theinsertion group 104 of the catheter insertion device 100 is illustratedalong with an assembled view of the catheter group 102. FIGS. 3B and 3Cillustrate a perspective view and a side view, respectively, of theassembled catheter group 102 and insertion group 104 of the catheterinsertion device 100. The insertion group 104 includes the handle 110that is made up of a right housing 126 and a left housing 128 that areconnected together. Top arm 127 and bottom arm 129 are formed in thedistal region of the handle 110. A needle cannula 130 is held within thehandle 110 and a guidewire 132, which slides through the lumen definedby the needle cannula 130, is also held within the handle 110. Theneedle cannula 130 may be anchored within the handle 110 by aninterference fit within an inner channel defined by the handle 110, byan adhesive, by a threaded connection, or the like. In someimplementations, the needle cannula 130 may be, for example, a 24 gaugeneedle.

A needle safety clip 134 is placed around the outer surface of theneedle cannula 130 to cover the sharp needle tip 131 followingseparation of the insertion group 104 from the catheter group 102. Aneedle guard 137 covers the portion of the needle cannula 130 extendingfrom the handle 110 before initial use of the catheter insertion device100. A first actuator, such as a slider 138, is connected to the top ofthe handle 110 and to the guidewire 132 and slides the guidewire 132relative to the handle 110 in both proximal and distal directions. Insome implementations, the guidewire 132 may be a spring wire guide, suchas a coiled or a coil-less spring wire guide. The length of theguidewire 132 is selected such that, before the slider 138 is actuated,the distal end of the guidewire does not extend beyond the sharp needletip 131 of the needle cannula 130.

The guidewire 132 may have a variable stiffness, as discussed in furtherdetail below. In some implementations, the guidewire 132 may have anouter diameter that is substantially uniform and less than or equal to0.010 inches (0.0254 centimeters). Preferably, the guidewire 132 has anouter diameter that is less than or equal to 0.010 inches when theneedle cannula 130 is a 24 GA needle and the elongated catheter 106 is a22 GA catheter, so that the guidewire 132 may fit within the lumendefined by the 22 GA catheter. In other implementations, the guidewire132 may have a varying diameter that narrows distally, such that thediameter of the guidewire 132 is the smallest at a distal end of theguidewire 132. When the guidewire 132 is fully advanced, the largerdiameter section is immediately distal to the needle 130, which helps toguide the catheter 106 during advancement and also directs thecatheter's movement during the initial part of the advancement. Further,the distal tip of the guidewire 132 has a small outer diameter so thatit is sufficiently flexible to help the guidewire 132 travel a tortuouspath out of the needle 130 and into the lumen of the vessel. Theguidewire also comprises a large diameter tip, such as a tip shaped likea ball so that it is not sharp. Such a large ball-shaped tip helps theclinician determine whether the entire guidewire is removed after use,since the clinician can see if the ball is there, thus indicating thatno piece of the guidewire was left behind. Moreover the ball-shaped tipat the distal end of the guidewire 132 is not sharp so as to avoidpuncturing a patient's vasculature during operation.

In some implementations, the guidewire 132 may be made of a metal, suchas a metal alloy. For example, the guidewire 132 may be made of an alloyof nickel and titanium. In some implementations, the guidewire 132 maybe coated with polysulfones, polyfluorocarbons, polyolefins, polyesters,polyurethanes, blends and/or copolymers.

A second actuator, such as a release 140, is also connected to thehandle 110 of the insertion group 104 and to the catheter group 102. Therelease is configured to slide the catheter group 102 relative to thehandle 110 in a distal direction. The release 140 includes a proximalarm 174 having an enlarged proximal end 141. A needle support 142 isattached to a proximal region of the handle 110 and swings upward anddownward relative to the handle 110. In particular, the needle support142 is rotationally coupled to the top arm 127 by a pivot member 144.

A catheter advancer base 318 is removably connected to the catheter hub118 and configured to slidably engage the bottom arm 129 of the handle110, as illustrated in FIG. 3D. The needle support 142 may comprise arigid plastic material to support the needle cannula 130 from bendingduring insertion into a patient's vasculature. The needle support 142includes two parallel walls 143 separated by a distance slightly greaterthan the outer diameter of the elongated catheter 106 in which theneedle cannula 130 passes in order to stabilize lateral movement of theneedle cannula 130 during insertion of the needle in the vasculature ofthe patient. This stabilization is especially important for insertion ofthe needle relatively deep in the tissue of the patient, such as withinan organ of the patient. Additionally, the needle support may furtherinclude a textured outer surface to aid gripping by a practitionerduring insertion of the catheter into the vasculature of a patient.Examples of such a textured outer surface include various patterns ofprotrusions, divots, grooves, channels and bumps, among others. In otherimplementations, the textured surface may be formed of a differentmaterial, such as rubber, or may be formed as a roughened surfacedirectly on the needle support 142. In some implementations, suchexamples of a textured surface may also be added to regions of thecatheter advancer base 318, such as to a grip arm 321 or grip recess322, among other areas, in order to aid with gripping.

As illustrated in FIGS. 3E and 3F, the needle support 142 also includesa top portion 147 that abuts the bottom surface of the slider 138 beforethe slider is slid proximally in order to prevent swinging of the needlesupport 142 while the catheter insertion device 100 is being inserted inthe vasculature of the patient. A lip 149 may be provided on the needlesupport 142 that defines a seat region configured to hook around adistal end of the bottom arm 129 of the housing in order to prevent theneedle 130 and/or the catheter 106 from popping out of the needlesupport 142 prematurely. Further, the needle support 142 may comprise atrapezoidal or other geometric shape, and may have an extendedlongitudinal length, for example 2 cm, configured to provide additionalsupport to the catheter.

As shown in FIG. 3G, the needle support 142 is free to swing about apivot member 144 when the slider 138 is retracted to the extent in whichit no longer abuts the top portion 147 of the needle support. Thecatheter advancer base 318 is configured to receive the catheter hub 118of the catheter group 102, as will be discussed in greater detail below.A retaining member, such as a protruding clip 323, is provided on thecatheter advancer base 318 and is configured to further secure the wingsof the catheter hub 118 to help retain the catheter hub 118 to thecatheter advancer base 318 during deployment.

Referring to FIG. 3H, the needle guard 137 includes an open channel 260defined by two parallel side walls 262. A bottom longitudinal featureand a top longitudinal feature between the parallel side walls 262secure around the needle cannula 130. As such, the bottom and toplongitudinal features are spaced apart by a distance slightly greaterthan the outer diameter of the catheter 106. A tab 268 may be providedat the proximal end of the needle guard 137 to allow the practitioner toinitially lift the needle guard 137 out of contact with the slider 138,and then push the needle guard 137 distally until the proximal ends ofthe bottom and top longitudinal features are distal of the sharp needletip 131. At this point, the needle guard 137 disengages from theinsertion group 104 and may be removed to expose the sharp needle tip131.

Referring to FIG. 4A, the catheter advancer base 318 and the needlesupport 142 are shown isolated from the rest of the catheter insertiondevice 100. FIG. 4B shows the catheter group 102 engaged with thecatheter advancer base 318 and the needle support. An upper surface ofthe catheter advancer base 318 includes a catheter seat 319 configuredto matingly receive the catheter hub 118. In one implementation, theretaining member 323 may be configured to allow the catheter hub 118 tosecurely snap into the catheter seat 319. A pair of spaced apartfasteners, such as pins 320, are provided within the catheter seat 319for connecting to respective connector holes on each wing section, whichextend outwardly on opposing sides of the catheter hub 118. The catheterhub 118 stays connected to and moves with the catheter advancer base 318when the catheter advancer base is advanced distally during the catheterinsertion procedure, as will be discussed in detail below.

The catheter advancer base 318 may be disconnected and removed from thecatheter hub 118 during dressing of the catheter 106 to a patient. Thecatheter advancer base 318 is also configured to stay with the catheter106 during advancement and may disconnected therefrom during dressing. Alongitudinal slide groove 324 provided on the bottom surface of thecatheter advancer base 318 defines a guide track that is configured toslidingly engage the bottom arm 129 of the housing. This guide track isconfigured to create a sliding motion of the catheter advancer base 318along the bottom arm 129 and also prevent twisting of the catheteradvancer base 318 and catheter hub 118 about their longitudinal axisduring such sliding motion when they are advanced forward duringcatheter insertion. Accordingly, the guide track is configured preventtorsion of the catheter advancer base 318, and thus also prevent torsionof the catheter group 102 and its associated components, when thecatheter advancer base rides on the bottom arm 129 of the handle duringcatheter insertion.

A grip arm 321 is provided on each side of the catheter advancer base318, and a grip recess 322 is also provided on each side of the catheteradvancer base 318. The grip arms 321 and grip recesses 322 allow foralternate grip positions of the catheter advancer base 318 by apractitioner, including a choked up hand grip position. For instance, insuch a choked up hand position, the user may grip the catheter insertiondevice 100 using one hand by placing a thumb in the grip recess 322located on a first side of the catheter advancer base 318, and a middlefinger in the grip recess 322 located on an opposite second side of thecatheter advancer base 318. The user's index finger may then be curledup so that it can manipulate the slider 138. In this choked up handposition, the closer a user's hand is located toward the distal end ofthe handle allows for improved control of gripping and advancing thecatheter advancer base 318 during operation. The catheter advancer base318 may be symmetric about its longitudinal axis to allow for bothright-handed and left-handed placement by a user.

Referring to FIG. 5A, a cross-sectional side view of the right housing126 including the slider 138 and the guidewire 132 is illustrated. Thehandle 110 includes a looped proximal end 151 through which theguidewire 132 passes. In particular, the guidewire 132 passes throughthe channel 153 defined by the handle 110. The diameter of the channel153 is slightly greater than the diameter of the guidewire 132 so thatthe guidewire 132 stably passes through the channel 153. The slider 138can be slid by a finger, such as the index finger in overhand operationor the thumb in underhand operation, of a practitioner proximally anddistally within a chamber 157 defined by the handle 110. The chamber 157is sized to be slightly larger than the slider 138 to stabilize themovement of the slider 138 within the chamber 157.

Due to the looping of the guidewire 132 within the looped proximal end151, proximal movement of the slider 138 translates into distal movementof the distal tip of the guidewire 132 and vice versa. The looping ofthe guidewire 132, as opposed to a linear geometry, also enablesone-handed operation of the catheter insertion device 100 whilemaintaining continuous grip of the gripping features 148 of the handle110. In addition, the looping of the guidewire 132 reduces thelikelihood of piercing the vasculature of the patient during advancementof the guidewire 132 due to the force of the practitioner beingindirectly applied to the guidewire 132.

Referring to FIG. 5B, a cross-section view of the assembled handle 110with the guidewire 132 and the slider 138 is illustrated. The handle 110includes gripping features 148 that help the practitioner grip thehandle 110 of the catheter insertion device 100. A right-handedpractitioner can, for example, grip the gripping feature 148 on the lefthousing 128 using his thumb and grip the gripping feature 148 on theright housing using his middle finger. Alternatively, a left-handedpractitioner can, for example, grip the gripping feature 148 on the lefthousing 128 using his middle finger and grip the gripping feature 148 onthe right housing using his thumb. The handle 110 can be gripped by thepractitioner overhand or underhand using the same fingers. The grippingfeature 148 may comprise a plurality of depressed lines, grooves,corrugations, projections, or a roughened surface, among others, formedon the outer surface of the handle 110. For example, raised lines may beformed in place of the depressed lines, a textured surface may beformed, a plurality of bumps may be formed, or a different material,such as rubber, may be provided over the region of the handle 110corresponding to the gripping features 148.

Three openings are defined by the front face 150 of the handle 110. Thebottom opening 152 is sized to receive the rigid hub cap 124 of thecatheter group 102. In particular, the diameter of the bottom opening152 is slightly greater than the diameter of the rigid hub cap 124. Themiddle opening 154 is sized to receive the guidewire 132 and the needlecannula 130, and the top opening 156 is sized to receive the slider 138and the proximal arm 174 of the release 140. The top opening 156includes a wider bottom region that receives the slider 138 and anarrower top region that receives the proximal arm 174 of the release140. The bottom opening 152 and the middle opening 154 are separated bya portion of the handle 110, whereas the middle opening 154 and the topopening 156 are not separated to allow a bottom arm 158 of the slider138 to slide within middle opening 154, as explained in greater detailbelow.

In particular, referring to FIG. 6, a transparent side view of a portionof the slider 138 is illustrated. The slider 138 includes a bottom arm158 extending from the bottom of the slider 138 in a directionperpendicular to the longitudinal axis of the slider 138. The bottom arm158 includes a through hole 160 that receives the proximal end 133 ofthe guidewire 132. The proximal end 133 may include a ball 162 to anchorthe tip of the proximal end of the guidewire 132 in place. The throughhole 160 has an internal diameter that is slightly larger than the outerdiameter of the guidewire 132 but slightly smaller than the diameter ofthe ball 162 formed at the tip end of the guidewire 132. The guidewire132 is therefore secured within the through hole 160 by an interferencefit. The through hole 160 does not extend along the entirety of thelength of the bottom arm 158, such that the distal end of the throughhole 160 is closed. Although the ball 162 is secured within the throughhole 160 by an interference fit, in some implementations, the ball 162may be secured by an adhesive, by a threaded connection, or the like.

Due to the interference fit between the through hole 160 and theguidewire 132, as the slider 138 is moved in a longitudinal directionfor a given distance, the guidewire will also move in the oppositedirection for the same distance and vice versa. Stated another way, theportion of the guidewire 132 that is between the slider 138 and the loopportion in the handle will move in the same direction as the slideritself. Conversely, the portion of the guidewire 132 that is between theloop portion of the handle and the distal tip will move in the oppositedirection of the slider 138. The slider 138 includes one or more grips164 that allow a finger, such as the index finger in an overhandoperation or the thumb in an underhand operation, of the practitioner topredictably actuate the slider 138 in either a distal or proximaldirection. In some implementations, the grips 164 may be shaped likearrows that point in the proximal direction. Adjacent to each grip 164may be an indicator 166, such as a number, that indicates a relativeextension of the guidewire 132 distally from the sharp needle tip 131.

The guidewire 132 may further comprise a variable stiffness thatfacilitates insertion of the catheter 106 into the vasculature of apatient. In one implementation, the guidewire 132 may comprise varioussegments, such as a first segment defining a thin section of increasedflexibility, a second segment defining a tapered transitioned section,and a third segment defining a thick and rigid section that assists thecatheter 106 in following bends in the guidewire 132. The third segment,which is nearest to the catheter 106 when the variable stiffnessguidewire is fully extended, has the most stiffness which helps thecatheter more easily follow any bends of the guidewire during insertioninto a patient's vasculature. The stiffness gradually decreases towardsthe distal tip of the guidewire, such that the first segment is the mostflexible region since it has the smallest diameter, which may be, forexample, between 0.005 in and 0.006 in. The increased flexibility of thefirst segment allows it to easily bend upon entry into the vasculaturein order to minimize piercing through the vasculature wall. Aspreviously noted above, the ball-shaped distal tip of the guidewire 132also helps minimize such piercing through the vasculature wall. Thelength of the segment of the guidewire may vary. In one implementation,for example, the length of the first and third segments may beapproximately 1.5 cm, and the length of the second segment may beapproximately 1.0 cm.

FIG. 7A shows a portion of the catheter insertion device depicting therelease 140 and the catheter advancer base 318, and FIG. 7B shows aportion of the catheter insertion device depicting the release 140without the catheter advancer base 318. The distal side of the release140 includes a notch 168 configured to receive the side port 121 of therigid hub 120. The release 140 is sized to be received from around thebottom arm 129 to the slider 138. The notch 168 is sized to be slightlylarger than the diameter of the side port 121 to stably secure the sideport 121. When the practitioner actuates the release 140 in a distaldirection using, for example, his index finger, the catheter group 102is also actuated in the distal direction by the same distance throughthe interface between the notch 168 and the side port 121.

As shown in FIG. 7C, the release 140 includes a continuous side wall170. If the practitioner's finger were to push down onto the slider 138or top arm 127 of the handle 110 while the needle cannula 130 is stillin the vasculature of the patient, the resulting downward movement ofthe needle cannula 130 may cause damage to the vasculature of thepatient. As such, the release 140 includes a distal lip 172 that extendsradially outward from the release 140 in order to help prevent thepractitioner's finger from slipping past the distal end of the release140.

The release 140 also includes a proximal arm 174 having an enlargedproximal end 141. The proximal arm 174 slides within the top opening 156of the handle 110. The enlarged proximal end of the release 140 isdimensioned to be larger than the top opening 156 so that distalmovement of the release 140 is limited to the length of the proximal arm174, and so that the release 140 does not separate from the handle 110.The release 140 may also include a grip 176 that allows a finger, suchas the index finger in an overhand operation or the thumb in anunderhand operation, of the practitioner to predictably actuate therelease 140 in either a distal or proximal direction.

Referring to FIG. 8A, a partially transparent perspective view of aregion of the assembled catheter insertion device 100 is illustrated.The bottom arms 129 of the right housing 126 and the left housing 128abut against one another to support the weight of the catheter hub 118.The top arms 127 of the right housing 126 and the left housing 128 arespaced apart by a distance slightly greater than the width of the needlesupport 142 to allow the needle support 142 to swing upwards duringremoval of the catheter group 102. The outer surface of each oppositespaced apart parallel wall 143 of the needle support 142 includes apivot member 144, such as a hinge, pivotally connected to thecorresponding inner surface of each spaced apart top arm 127 of thehandle.

The needle support 142 includes two parallel walls 143 that areperpendicular to the plane of the top surface of the bottom arms 129. Asexplained above, the parallel walls 143 are spaced apart by a distanceslightly greater than the outer diameter of the elongated catheter 106to stabilize the needle cannula 130 during insertion into thevasculature of the patient. In various implementations, the parallelwalls 143 of the needle support 142 may be sized to mate with thecatheter or needle gauge size, such as 18 ga, 20 ga, or 22 ga, amongothers. Both top arms 127 also include a groove 178 configured toreceive a corresponding tongue of the needle guard 137. Such a tongueand groove connection stably secures the needle guard 137 to the handle110 to protect the catheter before use of the catheter insertion device100.

FIGS. 8A-8F illustrate various operating positions of the catheterinsertion device 100 during advancement of the catheter group 102 fromthe insertion group 104. When the slider 138 is in the fully extendedposition, as shown in FIG. 8B, the top portion 147 of the needle support142 abuts the bottom surface of the slider 138 to block the needlesupport 142 from swinging upward which in turn blocks the catheteradvancer base 318 from moving, thus locking the release 140 from beingactuated in order to retain the catheter group 102 in place between theneedle support 142 and the release 140. Upon sliding the slider 138proximally toward the handle 110, as will be discussed below, the topsurface 147 of the needle support 142 becomes free since it no longerabuts the bottom surface of the slider. Further, the release 140 becomesunlocked such that pushing it distally toward the needle support 142urges the catheter advancer base 318 distally into contact with theneedle support 142. The catheter advancer base 318 accordingly urges theneedle support 142 to swing upward about the pivot member 144, thuscreating a clearance for the entire catheter group 102 to bedisconnected from the insertion group 104, as shown in FIG. 8F, so thatthe catheter 106 can be advanced forward into the patient's vasculature.

Before the practitioner slides the slider 138 proximally, the distal end139 of the slider 138 extends beyond the distal end of the top arm 127and, as such, extends distally along a portion of the needle support 142without extending beyond the needle support. As shown in FIG. 8B, whichillustrates a cross-sectional view of the region of the assembledcatheter insertion device 100 along the center longitudinal plane of thehandle 110, the needle support is oriented in a support position suchthat the bottom surface of the slider 138 abuts against the top portion147 of the needle support 142 before the slider 138 is slid proximallyin order to prevent the needle support 142 from swinging out ofengagement with the catheter prior to being inserted in the vasculatureof the patient.

In this support position, or pre-advancement position, the needlesupport 142 blocks the catheter advancer base 318 and the catheter group102 from moving forward. A portion of the catheter 106 proximate to thedistal end of the needle support 142 is supported to resist force fromthree directions such as from the bottom, the left side, and the rightside. A portion of the catheter 106 proximate to the proximal end of theneedle support 142 is supported by the rigid catheter advancer base 318to resist force from a fourth direction, such as from the top. Theneedle support 142 thus provides sufficient support to the catheter 106in order to improve its rigidity in order to avoid excessive bendingduring insertion into the vasculature of a patient. A lip 149 isprovided on the bottom of the needle support 142 and is configured tohood around a distal end of the bottoms arms 129 of the handle in orderto prevent the catheter group 102 from popping out accidentally duringuse. Further, when the needle support 142 is oriented in the supportposition, the catheter advancer base 318 and the catheter hub 118 remainnested between the top and bottom arms 127, 129 of the housing 110, andbetween the release 140 and the needle support 142 to retain thecatheter group 102 during use.

FIG. 8C illustrates a cross-sectional view of the region of theassembled catheter insertion device 100 along the center longitudinalplane of the handle 110 following actuation of the slider 138 by thepractitioner. The distal end 139 of the slider 138 is slid proximal ofthe needle support 142 so that the top portion 147 no longer abuts thebottom surface of the slider 138 and is free to swing upwards as thecatheter group 102 is separated from the insertion group 104.

FIG. 8D illustrates a cross-sectional view of the region of theassembled catheter insertion device 100 along the center longitudinalplane of the handle 110 following actuation of the release 140 by thepractitioner. According to another aspect, the practitioner may advancethe catheter without using the release 140. As shown in FIG. 8D, therelease 140 is pushed forward toward the distal end of the handle suchthat it correspondingly pushes the rigid hub 120 distally so that thecatheter advancer base 318 contacts the needle support 142 and urges theneedle support 142 to swing upward about the pivot members 144.

The release 140 may be pushed forward until it reaches a stop position,after which the practitioner may continue advancing the catheter group102 by gripping the catheter advancer base 318 and moving it forward.According to another aspect, the practitioner may grip the extensionline 108, or more particularly an arm of the rigid hub that contains theextension line inside of it, to advance the catheter group 102 forward.As previously discussed, a practitioner may grip each grip recess 322 ofthe catheter advancer base 318 in a choked up hand position in order tofacilitate advancement of the catheter advancer base 318. As shown inFIG. 8E, the needle support 142 continues to swing out of the way of thecatheter advancer base 318 and catheter hub 118 during advancementthereof. The needle support 142 is therefore moved out of the path ofthe catheter advancer base 318 and the catheter hub 118 in order toallow the distal end of the catheter advancer base 318 and the catheterhub 118 to extend distally beyond the needle support 142. The catheteradvancer base 318 and the catheter hub 118 thus initially abut theneedle support 142, and distally move past the needle support 142 oncethe needle support 142 is urged by the catheter advancer base 318 toswing upward to provide clearance for full deployment of the cathetergroup 102, as shown in FIG. 8F. Thus, the catheter group is advanceddistally such that the catheter group 102 is distal of the distal end ofthe handle 110. At this point, the needle safety clip 134 is stillmounted to the rigid hub cap 124, as explained below.

Referring to FIG. 9A, a perspective view of the needle safety clip 134mounted to the rigid hub 120 is illustrated. Referring to FIG. 9B, arear view of the needle safety clip 134 is illustrated. Referring toFIG. 9C, a front view of the needle safety clip 134 is illustrated. Theneedle safety clip 134 includes a proximal wall 180 that includes around aperture 182 having a diameter slightly greater than the outerdiameter of the needle cannula 130. In some implementations, the roundaperture 182 may have a sharp inner surface to grip the outer surface ofthe needle cannula 130 when the needle cannula 130 is at an angle withrespect to the central axis of the round aperture 182. In other words,the sharp inner surface of the round aperture 182 digs into the outersurface of the needle cannula 130 when the needle cannula 130 is tiltedwith respect to the needle safety clip 134, as shown in FIG. 9D, toprevent movement of the needle cannula 130 with respect to the needlesafety clip 134.

Referring back to FIG. 9A, a top wall 184 extends distally of theproximal wall 180 and defines a top opening 186. The top opening 186allows the spring arm 188 to extend partially above the top wall 184 inits compressed state, as shown in FIG. 9A. The spring arm 188 isillustrated having a C-shape. However, the spring arm 188 may bedesigned to have other shapes that are resilient and may be shaped tobe, for example, stepped, blocked, jagged, or amorphous. The top distalportion of the spring arm 188 is connected to the distal bottom surfaceof the top wall 184 to secure the spring arm 188 to the rest of theneedle safety clip 134. The spring arm 188 may be made of any flexiblematerial, such as, for example, plastic, stainless steel, aluminum ortitanium. The spring arm 188 may be made of the same material as therest of the needle safety clip 134 or made of a different materialhaving the desired characteristics.

A first distal wall 190 extends downward from the distal end of the topwall 184 and defines a first distal channel. A second distal wall 194curves upward from the first distal wall 190 and defines a second distalchannel. A narrow tab 198 extends distally from the distal end of thesecond distal wall 194 and a broad tab 200 extends distally from thenarrow tab 198. The narrow tab 198 is received within a narrow recess202 at the top of the rigid hub cap 124 and the broad tab 200 isreceived within a broad recess 204 at the top of the rigid hub cap 124to mount the needle safety clip 134 to the rigid hub cap 124. When theneedle safety clip 134 is mounted to the rigid hub cap 124, the narrowtab 198 prevents lateral movement of the needle safety clip 134 whilebroad tab 200 prevents longitudinal movement of the needle safety clip134.

Turning back to FIG. 9C, the first distal wall 190 defines a channelhaving a round top region 191 and a rectangular bottom region 192. Thediameter of the round top region 191 is slightly larger than the outerdiameter of the needle cannula 130 to allow the needle cannula 130 toslide through the round top region 191 with low friction and to preventlateral movement of the needle cannula 130. The rectangular bottomregion 192 has a width that is less than the outer diameter of theneedle cannula 130 to both keep the safety from springing upward untilthe needle tip is between the first distal wall and the second distalwall and block the needle cannula 130 from being able to extend distallypast the second distal wall 194, as explained in greater detail below.The second distal wall 194 also includes a round top region 195 that hasa diameter that is greater than the outer diameter of the needle cannula130 and a rectangular bottom region 196. The width of the rectangularbottom region 196 may be equal to the diameter of the round top region195 to allow the needle cannula 130 to move downward relative to theneedle safety clip 134 under force of the spring arm 188.

Referring to FIG. 9D, a perspective view of the needle safety clip 134released from the rigid hub 120 is illustrated. After the needle cannula130 is withdrawn from the rigid hub 120, it passes proximally throughthe round top region 195 of the second distal wall 194 and then throughthe round top region 191 of the first distal wall 190. Once the roundtop region 191 does not stabilize the needle cannula 130 (that is, oncethe width of the sharp needle tip, W_(n), becomes smaller than the widthof the rectangular bottom region 192), the needle safety clip 134 isfree to tilt relative to the needle cannula 130. The spring arm 188 thendecompresses, as shown in FIG. 9D, to push the needle safety clip 134upward. Because the needle cannula 130 is still within the roundaperture 182, it is gripped by the sharp inner edges of the roundaperture 182, which prevents longitudinal movement of the needle cannula130 with respect to the needle safety clip 134. As such, the firstdistal wall 190 and the second distal wall 194 cover the sharp needletip 131 and protect the practitioner from potential needle pricks.

Referring to FIG. 9E, a perspective view of the sharp needle tip 131 ofthe needle cannula 130 is illustrated. The sharp needle tip 131 may beformed by back grinding as illustrated, or in other implementations, thesharp needle tip 131 may have a lancet tip. The sharp needle tip 131tapers in the distal direction such that the width W_(n) of the sharpneedle tip 131 at a plane along the sharp needle tip 131 is equal to thewidth of the rectangular bottom region 192. As such, the needle cannula130 cannot extend distally past the first distal wall 190 beyond thatplane where the sharp needle tip 131 has the width W_(n) when the needlesafety clip 134 is released from the rigid hub 120 because the needlecannula 130 is wider than the rectangular bottom region 192 proximal ofthat plane. However, the length L_(n) may still extend distally beyondthe first distal wall 190 because the needle cannula 130 is thinner thanthe rectangular bottom region 192 distal of that plane. Therefore, asshown in FIG. 9F, to prevent exposure of the sharp needle tip 131 beyondthe second distal wall 194, the needle safety clip 134 is designed sothat the distance D_(c) between the first distal wall 190 and the seconddistal wall 194 in the axis aligned with the longitudinal axis of theneedle cannula 130 is greater than the length L_(n).

As shown throughout the FIGS. 9A-9F, the needle cannula 130 may furthercomprise a swage 270 having a pressed area of the metal tube near thedistal tip of the needle. The swage may have a substantiallyoval-shaped, or ellipse-shaped, cross sectional bulge that differs fromthe round cross section of the rest of the needle. The major diameter ofthe oval-shaped swage 270 is smaller than the cut out portions of thefirst and second distal walls 190, 194 of the safety latch 134, but islarger than the hole 182 in the proximal wall 180. This arrangementfurther ensures the safety clip 134 cannot be pulled distally off thetip of the needle.

Additionally, the minor diameter of the oval-shaped swage is larger thanthe width of the rectangular bottom region cut out 192 in the firstdistal wall of the safety latch. This ensures that the safety would notspring upward when the swage passes by the first distal wall 190 even ifthe rectangular bottom region 192 slot of the safety is parallel to theswage instead of being perpendicular, as it normally is. Moreover, theinner diameter of the swage 270 is greater than the outer diameter ofthe guidewire 132 so that the guidewire 132 can pass therethrough.

Referring to FIGS. 10A-B, partially transparent side views of thecatheter insertion device 100 during separation of the catheter group102 are illustrated. As explained above in connection with FIG. 8D, theslider 138 is initially slid proximally to provide clearance to allowthe needle support 142 to swing upwards, and then the release 140 isslid distally to push the catheter advancer base 318 forward. Thepractitioner can then fully advance the catheter into the patient, i.e.until the distal end of the catheter hub 118 almost touches the skin.The practitioner then uses the hand that is not grasping the handle 110to stabilize the catheter group 102. For example, the practitioner canuse his non-dominant hand to grasp the catheter hub 118 and/or the rigidhub 120 to stabilize the rigid hub 120 at a constant position within thevasculature of the patient. The practitioner can then pull the insertiongroup 104 proximally to remove the needle cannula 130 from the cathetergroup 102.

As shown in FIG. 10A, the insertion group 104 is pulled proximally tothe point where the sharp needle tip 131 of the needle cannula 130 isproximal of the second distal wall 194, but still distal of the firstdistal wall 190. As such, the plane where the sharp needle tip 131 hasthe width W_(n) is still distal of the first distal wall 190 and theneedle cannula 130 is stabilized within the round top region 191. Asshown in FIG. 10B, the width, W_(n), of the sharp needle tip 131 is lessthan the width of the rectangular bottom region 192 and, therefore, theneedle safety clip is free to tilt relative to the needle cannula. Thespring arm 188 then decompresses to tilt the needle safety clip upward,so that the second distal wall 194 and/or the first distal wall 190cover the sharp needle tip 131.

Referring to FIG. 11A, a perspective view of an implementation of theseal 218 is illustrated. The seal 218 is a two-part seal that includes aproximal part 220 and a distal part 222. Referring to FIG. 11B, theproximal part 220 has a flat proximal face 224 and a proximal region 228having a reduced diameter. The proximal part 220 defines an inner cavity230 that extends along a majority of the longitudinal axis of theproximal part 220. Relative to the seal 211, the inner cavity 230reduces the surface area of the seal 218 that the needle cannula 130contacts, thereby reducing the frictional forces applied duringadvancement of the catheter group and removal of the needle cannula 130.According to further aspects, lubricant may be added the cavity 230 tofurther reduce these frictional forces. Additionally, the cavity 230also provides empty space for the displaced seal material volume to moveinto when the cannula is inserted into the seal during the shelf life ofthe device, i.e. prior to removal of the cannula. This prevents a smallportion of the seal material from being displaced out the back of therigid cap of the catheter or distally into the catheter, i.e. inside therigid catheter hub.

Referring to FIG. 11C, the distal part 222 is solid and includes aproximal region 232 of reduced diameter. The diameter of the proximalregion 232 is slightly smaller than the diameter of the inner cavity atthe distal end of the proximal part 220 to prevent lateral movement ofthe distal part 222 relative to the proximal part 220 when the seal 218is assembled within the rigid hub 120 and the rigid hub cap 124. Thedistal part 222 also has a tapered distal region with a diameter thatreduces distally. The seal 218 may be made of a resilient material, suchas, for example, silicon, rubber, polyisoprene, or the like.

Referring to FIG. 11D, a partial cross-sectional view of the assembledrigid hub 120, two-part seal 218, and rigid hub cap 124 taken along theplane defined by the diameter of the rigid hub 120 and the longitudinalaxis of the side port 121 is illustrated. The proximal region 228 havingthe reduced diameter is compressed within the rigid hub cap 124 to forcethe seal material radially inward in response to pressure applied to theflat distal face 226. The flat distal face 226 is flush with the distalend of the rigid hub cap 124 to allow for complete evacuation of theinner volume of the rigid hub 120 when flushing the catheter insertiondevice 100.

As shown in FIG. 11D, the distal seal diameter is larger than thediameter of the mating cavity in the rigid hub. This helps to generate acompression force to prevent air or fluid leakage after theneedle/cannula is removed during routine use of the catheter by thepractitioner, such as for drawing blood or injecting fluid. Further, theradiused portion on the distal seal (in the middle of the assembly)mates with the corresponding radius on the inside of the rigid cap tofacilitate placement and location of the distal seal, as well as resistpressure from the distal end inside the catheter body and extension linein order to keep the seal in place. Additional compression forces on theproximal side of the seal further close off the previous hole from thecannula. Also, the proximal side of the seal may be flush, or justbeyond flush, with the outside of the rigid cap to allow cleaning of thehub.

Referring to FIG. 12, a perspective view of a distal region of theneedle cannula 130 is illustrated. The distal region of the needlecannula 130 includes one or more and, preferably, eight echogenicfeatures. The echogenic features may be, for example, through holes 258drilled within opposite sides of the needle cannula 130. Although thesharp needle tip 131 is echogenic when observed under ultrasound, thethrough holes 258 improve the echogenicity of the needle cannula 130. Inparticular, the through holes 258 are visible through the wall thicknessof the elongated catheter 106 under ultrasound. In addition, throughholes 258 allow for blood flow from within the lumen of the needlecannula 130 to the outer surface of the needle cannula 130. The bloodthen flows to the inner surface of the catheter 106 to allow for visualobservation of the blood.

The through holes 258 are angled relative to one another. For example,the through holes 258 are drilled 90 degrees apart from one another, asshown in FIG. 12. The different angles of the through holes 258 and thenumber of through holes 258 results in at least two echogenic featuresbeing visible under ultrasound at all times—one echogenic feature beingthe sharp needle tip 131 and the other being at least one of the throughholes 258. The two visible echogenic features enable the practitioner toknow the angle of insertion of the needle cannula 130.

The many features and advantages of the catheter insertion device 100are apparent from the detailed specification, and thus, the claims coverall such features and advantages within the scope of this application.Further, numerous modifications and variations are possible. As such, itis not desired to limit the catheter insertion device 100 to the exactconstruction and operation described and illustrated. Accordingly, allsuitable modifications and equivalents may fall within the scope of theappended claims.

What is claimed is:
 1. A catheter insertion device comprising: a handlehaving a body portion, a top arm extending distally from the bodyportion, and a bottom arm extending distally from the body portion; aneedle cannula having a proximal end located within the handle bodyportion and a sharp distal tip extending distally from the top andbottom arms; a catheter assembly removably coupled to the handle andconfigured to slide on the needle cannula, the catheter assembly havinga portion disposed in a space between the top arm and the bottom arm,the catheter assembly comprising an elongated catheter, a catheter hubconnected to the elongated catheter, and a catheter advancer baseremovably connected to the catheter hub, the catheter advancer basehaving a grip portion for gripping and advancing the catheter assemblyfrom a first position to a second position; a guidewire partiallydisposed within the handle; and a guidewire actuator connected to thehandle and to the guidewire, the guidewire actuator configured to slidealong the top arm of the handle for extending or retracting theguidewire relative to the handle.
 2. The catheter insertion deviceaccording to claim 1, wherein the catheter advancer base includes a pairof laterally extending grip arms configured to aid with gripping thecatheter assembly by a user.
 3. The catheter insertion device accordingto claim 2, wherein the catheter advancer base further comprises a seatportion configured to secure the catheter and the catheter hub to thecatheter advancer base.
 4. The catheter insertion device according toclaim 3, wherein the seat portion of the catheter advancer basecomprises a pair of spaced apart fasteners for securing the catheteradvancer base to the catheter hub such that the catheter hub staysconnected to and moves with the catheter advancer base when the catheteradvancer base is advanced distally during a catheter insertionprocedure.
 5. The catheter insertion device according to claim 2,wherein the catheter advancer base further comprises a retaining memberconfigured to secure the catheter hub to the catheter advancer base,such that the catheter hub stays connected to and moves with thecatheter advancer base when the catheter advancer base is advanceddistally during a catheter insertion procedure.
 6. The catheterinsertion device according claim 5, wherein a proximal end of theguidewire is connected to the guidewire actuator.
 7. The catheterinsertion device according to claim 6, wherein the top arm of the handleincludes a groove, the guidewire actuator including a portion disposedin the groove to guide the guidewire actuator when the guidewireactuator slides along the top arm of the handle to extend or retract theguidewire relative to the handle.
 8. The catheter insertion deviceaccording to claim 1, wherein the catheter advancer base is configuredto prevent twisting of the catheter assembly during movement of thecatheter assembly from the first position to the second position.
 9. Thecatheter insertion device according to claim 8, wherein the catheteradvancer base is configured to slide along the bottom arm of the handle.10. The catheter insertion device according to claim 9, wherein thecatheter advancer base includes a guide portion configured to receivethe bottom arm of the handle for guiding the catheter assembly from thefirst position to the second position.
 11. The catheter insertion deviceaccording to claim 1, further comprising a needle support connected tothe handle and movable between a closed position and an open position,the needle support configured to block distal advancement of thecatheter assembly when in the closed position, and the needle supportfurther configured to permit distal advancement of the catheter assemblywhen in the open position.
 12. The catheter insertion device accordingto claim 11, wherein the needle support is further configured tostabilize lateral movement of the needle cannula when the needle supportis in the closed position during an insertion procedure.
 13. Thecatheter insertion device according to claim 11, wherein the needlesupport includes a pair of parallel walls pivotally connected to thehandle, said needle support configured to support the needle cannulawhen the needle support is in the closed position,
 14. The catheterinsertion device according to claim 13, wherein said needle cannula isdisposed between the pair of parallel walls of the needle support whenthe needle support is in the closed position.
 15. The catheter insertiondevice according to claim 11, wherein the needle support cannot movefrom the closed position to the open position before the guidewireactuator is moved to extend the guidewire distally relative to thehandle.
 16. The catheter insertion device according to claim 11, whereinthe guidewire actuator abuts the needle support when the needle supportis in the closed position, wherein the guidewire actuator does not abutthe needle support when the needle support is in the open position. 17.The catheter insertion device according to claim 11, wherein the needlesupport is pivotally connected to a distal portion of the top arm of thehandle and configured to move relative to the handle upon abutment ofthe catheter advancer base with the needle support.
 18. The catheterinsertion device according to claim 1, further comprising a catheterassembly actuator connected to the handle, the catheter assemblyactuator being movable relative to the handle to slide the catheterassembly distally relative to the handle.
 19. The catheter insertiondevice according to claim 1, wherein the guidewire further has avariable stiffness.
 20. The catheter insertion device according to claim1, wherein the housing further includes a gripping surface to assist auser with single-handed operation of the catheter insertion device.